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  • Wykrzykowska, Joanna J (author)

Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.

  • Article/chapterEnglish2017

Publisher, publication year, extent ...

  • 2017
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-342873
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-342873URI
  • https://doi.org/10.1056/NEJMoa1614954DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • Collaborator Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.
  • BACKGROUND: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice.METHODS: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events.RESULTS: The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001).CONCLUSIONS: In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).

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  • Kraak, Robin P (author)
  • Hofma, Sjoerd H (author)
  • van der Schaaf, Rene J (author)
  • Arkenbout, E Karin (author)
  • IJsselmuiden, Alexander J (author)
  • Elias, Joëlle (author)
  • van Dongen, Ivo M (author)
  • Tijssen, Ruben Y G (author)
  • Koch, Karel T (author)
  • Baan, Jan (author)
  • Vis, M Marije (author)
  • de Winter, Robbert J (author)
  • Piek, Jan J (author)
  • Tijssen, Jan G P (author)
  • Henriques, Jose P S (author)
  • James, StefanUppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367(author)
  • Uppsala universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

Related titles

  • In:New England Journal of Medicine376:24, s. 2319-23280028-47931533-4406

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